Dissolvable films containing high concentrations of nonionic surfactants such as polysorbates to enhance high solid loadings

ABSTRACT

An oral care composition and method are described in which the composition includes a film or a plurality of film fragments entrained in a carrier. The film or plurality of film fragments comprises a relatively high concentration of nonionic surfactants. The composition and methods provide benefits including higher active material loading in the film formula for improved efficacy, and a reduced amount of film needed in a product, which at the same time delivering comparable or improved efficacy with lower loading of the film in the composition

BACKGROUND

This application relates to oral and personal care compositions, andmore particularly to compositions comprising a film entrained in acarrier, in which the film includes a relatively high concentration ofnonionic surfactants such as polysorbates. Such compositions include,for example, dentifrices. The high concentration of nonionic surfactantsenhance the solid loading capacity of the film.

The aesthetic appeal of such compositions is important, and can havesignificant effects on consumer acceptance and usage. Aesthetic effectshave been acknowledged to play an important role in consumer acceptanceof many products. Although such products have met with consumerapproval, the art seeks to further improve the aesthetic effects as wellas the cosmetic and therapeutic benefits of these products. Indeed, manysuch compositions known in the art are deficient in one or moreattributes.

Compositions for enhancing health, hygiene or appearance, such as oralcare compositions, skin care compositions and hair care compositions,are used by millions of people. These compositions are used for a widevariety of purposes, including for enhancing personal health, hygiene,and appearance, as well as for preventing or treating a variety ofdiseases and other conditions in humans and in animals.

The formulation of such compositions presents a number of challenges.They must be pharmaceutically and/or cosmetically acceptable for theirintended use. Compositions that contain therapeutic active materialspreferably deliver the active at effective levels, avoiding unduechemical degradation. Similarly, compositions containing cosmeticallyfunctional materials must deliver the material to, e.g., the oralcavity, skin or hair at effective levels under the conditions that theyare typically used by the consumer.

Water-soluble films for oral administration of therapeutic agents arewell known in the art. It is also known in the art to use such films foradministering a breath freshening agent, e.g., menthol. The known filmsfor administering breath freshening agents and/or active pharmaceuticalagents are generally comprised of at least one water-soluble polymersuitable for human consumption and at least one compound that enhancesthe wettability of the water-soluble polymer, typically selected frompolyalcohols, surfactants and plasticizers. For example, U.S. Pat. No.5,948,430, the disclosure of which is incorporated by reference hereinin its entirety, describes a monolayer film that can be adhered to theoral cavity to release a pharmaceutically or cosmetically activeingredient, wherein the film comprises at least one water-solublepolymer; at least one member selected from the group consisting of apolyalcohol, a surfactant and a plasticizer; at least one cosmetic orpharmaceutically active ingredient; and a flavoring agent.

U.S. Pat. No. 5,700,478, the disclosure of which is incorporated byreference herein in its entirety, describes a laminated device forcontrolled release of a substance within a mucosa-lined body cavityincluding a water-soluble adhesive layer comprised of a water-solublepolymer and a water-soluble plasticizer, and a water-soluble polymerlayer. This patent teaches a multiple layer laminate that dissolvesrelatively slowly for controlled or sustained release of a substance.

U.S. Pat. No. 4,900,552, the disclosure of which is incorporated byreference herein in its entirety, describes a trilaminate film suitablefor prolonged and sustained delivery of an active ingredient in a buccalcavity. The trilaminate includes a hydratable muco-adhesive base layer;a non-adhesive reservoir layer; and a water-impermeable barriersandwiched between and bonded to the base layer and the reservoir layer.This patent discloses slowly disintegrating films for prolonged orsustained release of a substance.

U.S. Pat. No. 5,047,244, the disclosure of which is incorporated byreference herein in its entirety, discloses a therapeutic dosage formcomprising an anhydrous but hydratable monolithic polymer matrix thatcontains amorphous fumed silica as well as a therapeutic agent, and awater-insoluble barrier layer secured to the polymer matrix and defininga non-adhesive face. This patent does not disclose rapidlydisintegrating films, but instead contemplates compositions that arecapable of providing improved availability of therapeutic agents from acontrolled release muco-adhesive carrier system.

U.S. Pat. No. 6,669,929, and U.S. Patent Application Publication No.2003/0053962, the disclosures of each of which are incorporated byreference herein in their entirety, disclose film forming agents usefulin oral care compositions. The films dissolve in the mouth and releasefunctional components, typically flavorants.

It is known to incorporate flavorants, colorants, and some activecomponents in films that dissolve in the oral cavity. These films areused either by themselves as breath freshening strips, teeth whiteningstrips, or as polymer flakes dispersed throughout an oral carecomposition. It also is known to incorporate zinc salts in dentifriceformulations.

Dissolvable films are capable of entrapping actives and other types ofsolid ingredients. However, the amount of solids can overload the filmmatrix creating a limit on the amount of solids it can contain. Thiscreates a barrier as to how much can be loaded into the film and canincrease the cost of films used in products

Thus, there is an ongoing need for new oral and personal carecompositions, and methods of their use.

SUMMARY

The present invention provides, in various embodiments, oral andpersonal care compositions comprising a film entrained in a carrier, inwhich the film includes a relatively high concentration of nonionicsurfactants such as polysorbates. In one embodiment, the film isprovided as a plurality of film fragments. In various embodiments, thepresent invention provides compositions comprising a plurality oflamellar fragments in a carrier.

In one embodiment, the oral care composition comprises a film entrainedin a carrier, in which the film comprises a nonionic surfactant in anamount from 5% by weight of the film to 20% by weight of the film.Increasing the solid loading in the film formula increases the deliveryof actives per area which is important for delivering superior efficacy.

The embodiments also provide methods for making the film and methods foradministering an active compound to a human or animal subject in needthereof, the method including topically applying to the subject an oralcare composition comprising a film entrained in a carrier, wherein thefilm comprises an nonionic surfactant in an amount from 5% by weight ofthe film to 20% by weight of the film. In various methods, such methodsfurther comprise disrupting the film after the topical application.

Compositions and methods of this invention afford benefits overcompositions and methods among those known in the art. Such benefitsinclude one or more of increased consumer acceptability, improvedamounts of available actives, decreased adverse reactions brought aboutby the presence of actives, enhanced aesthetics, improved stability foractive or other functional materials, and controlled delivery of activematerials. Further benefits and embodiments of the present invention areapparent from the description set forth herein.

DESCRIPTION

The present invention provides compositions and methods foradministration to, or use with, a human or other animal subject.Preferably, specific materials and compositions to be used in thisinvention are, accordingly, pharmaceutically- orcosmetically-acceptable. As used herein, such a “pharmaceuticallyacceptable” or “cosmetically acceptable” component is one that issuitable for use with humans and/or animals to provide the desiredtherapeutic, sensory, decorative, or cosmetic benefit without undueadverse side effects (such as toxicity, astringent taste, irritation,and allergic response) commensurate with a reasonable benefit/riskratio. The following definitions and non-limiting guidelines must beconsidered in reading and interpreting the description of this inventionset forth herein.

The headings (such as “Introduction” and “Summary,”) used herein areintended only for general organization of topics within the disclosureof the invention, and are not intended to limit the disclosure of theinvention or any aspect thereof. In particular, subject matter disclosedin the “Introduction” may include aspects of technology within the scopeof the invention, and may not constitute a recitation of prior art.Subject matter disclosed in the “Summary” is not an exhaustive orcomplete disclosure of the entire scope of the invention or anyembodiments thereof.

The citation of references herein does not constitute an admission thatthose references are prior art or have any relevance to thepatentability of the invention disclosed herein. All references cited inthe Description section of this specification are hereby incorporated byreference in their entirety.

The description and specific examples, while indicating embodiments ofthe invention, are intended for purposes of illustration only and arenot intended to limit the scope of the invention. Recitation of multipleembodiments having stated features is not intended to exclude otherembodiments having additional features, or other embodimentsincorporating different combinations of the stated features. SpecificExamples are provided for illustrative purposes of how to make, use andpractice the compositions and methods of this invention and, unlessexplicitly stated to recite activities that have been done (i.e., usingthe past tense), are not intended to be a representation that givenembodiments of this invention have, or have not, been performed.

As used herein, the words “preferred” and “preferably” refer toembodiments of the invention that afford certain benefits, under certaincircumstances. However, other embodiments may also be preferred, underthe same or other circumstances. Furthermore, the recitation of one ormore preferred embodiments does not imply that other embodiments are notuseful, and is not intended to exclude other embodiments from the scopeof the invention. As used herein, the word “include,” and its variants,is intended to be non-limiting, such that recitation of items in a listis not to the exclusion of other like items that may also be useful inthe materials, compositions, devices, and methods of this invention. Ina similar manner, the description of certain advantages or disadvantagesof known materials and methods is not intended to limit the scope of theembodiments to their exclusion. Indeed, certain embodiments may includeone or more known materials or methods, without suffering from thedisadvantages discussed herein.

As used herein, the term “comprising” means that other steps and othercomponents that do not affect the end result may be utilized. The term“comprising” encompasses the expressions “consisting of,” and“consisting essentially of” The expression “effective amount,” as usedherein denotes an amount of a compound or composition sufficient tosignificantly induce a positive benefit, preferably an oral healthbenefit, but low enough to avoid serious side effects, i.e., to providea reasonable benefit to risk ratio, within the sound judgment of aperson having ordinary skill in the art. The use of singular identifierssuch as “the,” “a,” or “an” is not intended to be limiting solely to theuse of a single component, but may include multiple components.

The oral care compositions of the various embodiments preferably are inthe form of a dentifrice. The term “dentifrice” as used throughout thisdescription, denotes a paste, gel, or liquid formulation. The dentifricemay be in any desired form, such as deep striped, surface striped,multi-layered, having a gel surround the paste, or any combinationsthereof. The film contained in the oral care composition may be of anydesired shape or structure, including multiple small strips, or onecontinuous strip.

The expressions “carrier” or “aqueous carrier” as used throughout thisdescription denote any safe and effective materials for use herein. Suchmaterials include, for example, thickening agents, humectants, ionicactive ingredients, buffering agents, anticalculus agents, abrasivepolishing materials, peroxide sources, alkali metal bicarbonate salts,surfactants, titanium dioxide, coloring agents, flavor systems,sweetening agents, antimicrobial agents, herbal agents, desensitizingagents, stain reducing agents, and mixtures thereof.

All percentages and ratios used herein are by weight of the oral carecomposition, unless otherwise specified. All measurements are made at25° C., unless otherwise specified.

The present invention provides oral or personal care compositionscomprising a film entrained in a carrier, wherein the film comprises arelatively high concentration of nonionic surfactants such aspolysorbates. As referred to herein, an “oral or personal carecomposition” is any composition that is suitable for administration orapplication to a human or animal subject for enhancing the health,hygiene or appearance of the subject, including the prevention ortreatment of any physiologic condition or disorder, and providingsensory, decorative or cosmetic benefits and combinations thereof.Compositions among those provided herein include oral care compositions,skin care compositions, hair care composition, topical pharmaceuticalcompositions, and ocular compositions. By “oral care composition” asused herein is meant a composition for which the intended use caninclude oral care, oral hygiene, or oral appearance, or for which theintended method of use can comprise administration to the oral cavity.

Embodiments of this invention comprise a film. As referred to herein, a“film” is a material having a substantially lamellar structure. A“lamellar” structure has, or is capable of having, a size in one or twodimensions (e.g., the x- or y-dimensions) that is substantially greaterthan the thickness of the structure in a third dimension (e.g., thez-direction). Lamellar structures among those useful herein includethose that are substantially planar, layered, or lamelliform. In oneembodiment, the lamellar structure is substantially planar, having asize in both the x- and y-dimensions that is substantially greater thanthe z-direction. In other embodiments, the lamellar structure isnon-planar. In one embodiment, a film of this intention comprises asubstantially continuous surface that can appear as a substantially flatsurface, although in some embodiments the film is deformed. In suchembodiments, the film can have any of a number of shapes, includinghaving a smooth curved surface.

Films among those useful herein may be rigid or plastic, comprising anyof a variety of materials, including materials selected from the groupconsisting of film forming materials, clays, waxes, and mixturesthereof. In one embodiment, the film comprises a film forming polymer.Film forming polymers among those useful herein include materialsselected from the group consisting of water soluble polymers, waterdispersible polymers, water insoluble polymers, and mixtures thereof.

In some embodiments, a film comprises at least one film formingmaterial. In certain embodiments, a film forming material is a polymer.Polymers useful herein include hydrophilic polymers and hydrophobicpolymers. In certain embodiments, the polymer is a water solublepolymer. In some embodiments, the polymer is a water soluble, breakablepolymer that dissolves during use, such as, for example, duringtoothbrushing. The dissolution can occur as a result of, for example,shearing and/or exposure to a solvent comprising a high concentration ofwater, such as saliva. In some embodiments, the polymer is insoluble butbreakable in water by being dispersible, i.e., the polymer breaks downinto small fragments, for example, as a result of shearing. In someembodiments, a polymer is insoluble but swellable. In configurations inwhich a polymer does not break down during use, the polymer can be awater-repellant polymer or an aqueous-stable hydrophilic polymer such ascertain types of cellulose, for example paper. In some embodiments, afilm fragment can comprise a mixture of film forming materials.

Water soluble polymers among those useful herein include celluloseethers, methacrylates, polyvinylpyrollidone, and mixtures thereof. Inone embodiment, the polymer is a cellulose ether, including thoseselected from the group consisting of hydroxyalkyl cellulose polymerssuch as hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose,hyrdoxyethyl cellulose, methyl cellulose, carboxymethyl cellulose, andmixtures thereof. Other polymers among those useful herein includepolyvinylpyrrolidone, cross-linked polyvinyl pyrrolidone,polyvinylpyrrolidone-vinyl acetate copolymer, polyvinylalcohol,polyacrylic acid, poly acrylate polymer, cross-linked polyacrylatepolymer, cross-linked polyacrylic acid (e.g, Carbopol®), polyethyleneoxide, polyethylene glycol, poly vinylalkyl ether-maleic acid copolymer(such as Gantrez®) and carboxy vinyl polymer; natural gums such assodium alginate, carrageenan, xantham gum, gum acacia, arabic gum, guargum, pullulan, agar, chitin, chitosan, pectin, karaya gum, zein,hordein, gliadin, locust bean gum, tragacantha and otherpolysaccharides; starches such as maltodextrin, amylose, high amylosestarch, corn starch, potato starch, rice starch, tapioca starch, peastarch, sweet potato starch, barley starch, wheat starch, waxy cornstarch, modified starch (e.g. hydroxypropylated high amylose starch),dextrin, levan, elsinan and gluten; and proteins such as collagen, wheyprotein isolate, casein, milk protein, soy protein and gelatin.

Non-limiting examples of water dispersable and swellable polymersinclude modified starch, alginate esters, divalent or multivalent ionsalts of alginates. Non-limiting examples of water insoluble polymersinclude polymers soluble in at least one organic solvent, such ascellulose acetate, cellulose nitrate, ethylene-vinyl acetate copolymers,vinyl acetate homopolymer, ethyl cellulose, butyl cellulose, isopropylcellulose, shellac, silicone polymer (e.g. dimethylsilicone), PMMA (polymethyl methacrylate), cellulose acetate phthalate and natural orsynthetic rubber; polymers insoluble in organic solvents, such ascellulose, polyethylene, polypropylene, polyesters, polyurethane andnylon.

The films useful in the various embodiments can be made in accordancewith the methods described in U.S. Pat. No. 6,669,929, and U.S. PatentApplication Publication No. 2003/0053962, the disclosures of which areincorporated by reference herein in their entirety. The nonionicsurfactants contained within the film can be incorporated into the filmduring film manufacture using techniques known in the art. A personhaving ordinary skill in the art will be capable of making the filmcontaining the high concentration of nonionic surfactants, using theguidelines provided herein.

The polymer matrix used in many dissolvable films, which are preferredin certain embodiments, has a limited capacity of the amount of solidsit can hold. This creates a barrier as to how much can be loaded intothe film and can increase the cost of films used in products. Certainformulation modifications can be performed, however, to increase theintegrity of the film matrix to hold high loadings of solids. Thepresent inventors have discovered that by increasing the amount ofnonionic surfactants, more actives can be loaded into the film thancould be done previously. A film having a higher concentration ofactives allows more actives per area to be delivered, and also reducesthe amount of film needed to deliver these higher amounts. The improvedhigher loading film formula provides higher deposition onto surfaces forsuperior efficacy. Also, improving the film formulation to hold a higherloading of actives can reduce the amount of total film needed in aproduct, while at the same time, delivering the same efficacy as with alower loading of film. Without wishing to be bound by any theory ofoperation, the present inventors believe that the nonionic surfactantsoperate to help other ingredients dissolve into a solvent and aid in theformation of emulsions by reducing the surface tension of the substancesto be emulsified. In addition, the nonionic surfactants do not interferewith other ingredients in the formula as is possible with anionic andcationic surfactants. As such, many different active ingredients may beused in a formulation with nonionic surfactants.

Preferred nonionic surfactants include polysorbates such as polysorbate20, 40, 60, 80, or combinations thereof. Particularly preferredembodiments include polysorbate 80. Typical concentrations ofpolysorbates previously used in dissolvable film formulations are around2% dry weight to aid in film disintegration. The inventors havediscovered that by increasing the concentration of nonionic surfactantsin the film formula, a higher loading of solids can be formulated andthe speed of disintegration is not affected because of the solidsloading. The amount of nonionic surfactants included in a film can varyfrom 5% by weight of the film to 20% by weight of the film, preferablyfrom 10% by weight of the film to 18% by weight of the film, and mostpreferably 14% by weight of the film.

The amount of solids included in the film can vary from 20% to 65% byweight of the film, preferably from 30% to 55% by weight of the film,and most preferably 45% by weight of the film. The amount of filmincluded in the oral composition also can vary anywhere from 0.1% to5.0%, more preferably from 0.25% to 3.0%, and most preferably from 0.5%to 2.0% by weight. The amount of solids employed in the overall oralcomposition therefore can vary from 0.02% to 3.25%, based on the totalweight of the composition, typically from 0.08% to 1.5%, based on thetotal weight of the oral care composition.

In various embodiments, the oral care compositions comprise a pluralityof lamellar film fragments entrained in a carrier. In one embodiment,the composition comprises a film, wherein the film comprises lamellarfragments of the film material. In one embodiment, the compositioncomprises a carrier having distributed therein a plurality of lamellarfragments, wherein the fragments comprise a matrix and a therapeuticactive. In one such embodiment, the matrix comprises a film. Suchfragments may be of any of a variety of shapes or forms, includingsemi-solid or solid discrete portions, fragments, particles, flakes, orcombinations thereof. In various embodiments, the film comprises a firstplurality of fragments and a second plurality of fragments, wherein thefirst plurality of fragments differ in composition or appearance fromthe second plurality of fragments. Such difference in composition orappearance can be in any aspect of the composition of the fragment(e.g., different film components, different functional material,different formulation colorant), different appearance (e.g., shape,color, texture, refractive index, reflective index), or combinationsthereof.

In various embodiments, the fragments exhibit perceivable contrast withthe carrier. The perceivable contrast can be sensory contrast, such asoptical contrast, tactile contrast, taste contrast, or olfactorycontrast. In some configurations, optical contrast can be colorcontrast, or a difference in refractive index or reflective index. Insome configurations, color contrast can be imparted by one or morecolorants that comprise different components of the composition. Invarious embodiments, the present invention provides compositionscomprising a plurality of film fragments in a carrier, wherein saidfragments are visibly discernable. As referred to herein, “visiblydiscernable” refers to one or more characteristics of a fragment whichcause the fragment to have a different physical appearance, preferablyto the naked eye, relative to the carrier in which the fragment isentrained. Such characteristics include color, opacity, refractiveindex, reflective index, size, shape, and combinations thereof.

In various embodiments, the fragments have a non-random shape. In oneembodiment, a “non-random” shape is a shape which results from amanufacturing process of shaping, cutting, or other forming process bywhich a specific shape is imparted to a fragment. In such embodiments, anon-random shape is distinguished from such shapes that result fromsimple precipitation or grinding of a material. In one embodiment, a“non-random” shape is “repeating,” wherein the composition comprises aplurality of fragments have substantially the same shape. Such repeatingshape may have any of a variety of forms, and may be selected based on avariety of aesthetic or functional criteria. In certain embodiments, theshape of a film fragment can be a recognizable shape. In certainembodiments, a film fragment can comprise a nonrandom shape. Such shapesinclude simple geometric shapes, such as polygons and elliptical shapes,such as triangles, quadrilaterals (such as a square, a rectangle, arhombus), pentagons, hexagons, oval, and circles. In one embodiment, therepeating shape is a square. Repeating shapes include, in otherembodiments, shapes that are representative of figures or animate orinanimate objects, such as stars, hearts, gems, flowers, trees,shamrocks, a letter of an alphabet, numbers, animals, people, and faces.In various embodiments, the composition comprises a single repeatingshape. In other embodiments, the composition comprises a plurality offragments having a plurality of repeating shapes. In one embodiment, thecompositions of the present invention comprise a plurality of first filmfragments having a first repeated shape and a plurality of second filmfragments having a second repeated shape, wherein the first repeatedshape is different from the second repeated shape.

In various embodiments, the size of the fragments is not critical, andmay be determined pursuant to any of a variety of criteria, includingmanufacturing convenience, affect on visual appearance, surface area,affect on texture in the composition, and combinations thereof. In someembodiments, the film fragments can be up to 1 inch (25.4 mm) in lengthin the longest dimension. As referred to herein, “long dimension” is thedimension of a fragment in length or width (i.e., in the x- andy-dimensions, as the fragment is, or is deformed to be, in a planarshape) in a dimension substantially perpendicular to the “thickness” orshortest dimension of the fragment (i.e., the z-dimension). It isunderstood that in various embodiments comprising a plurality offragments, the fragments may be present in a range of sizes due to avariety of factors, including random variation in size, manufacturingtolerances, and intentional sizing or mixing of the fragments throughsieving or similar means. As referred to herein, sizes refer to theaverage size of fragments in a given plurality of fragments.

In various embodiments, the fragments are from 0.2 mm to 15 mm in longdimension. In various embodiments, the long dimension of the fragmentsis from 0.2 mm to 10 mm, from 0.5 mm to 10 mm, from 0.8 mm to 8 mm, from0.9 mm to 5 mm, from 1.0 mm to 5 mm, or from 1.5 mm to 2.5 mm. In someembodiments, the long dimension of the fragments is at least 3 mm, andcan be from 6 mm to 13 mm. In certain embodiments, a plurality of filmfragments are greater than 600 microns in the longest dimension. Incertain embodiments, a plurality of film fragments are greater than 1millimeter in the longest dimension.

In various embodiments, the fragments of the present invention have athickness of from 1 mil (thousandth of an inch, 25.4 microns) to 3 mils(76.2 microns). In various embodiments, the fragments have a thicknessof less than 4 mils or less than 100 microns and from 0.1 mils (2.54microns) up to 10 mils (254 microns), from 0.5 mils (12.7 microns) up to5 mils (127 microns), from 1.4 mils (35.6 microns) to 2.0 mils (50.8microns).

In some embodiments, the compositions of the present invention comprisefragments having an aspect ratio of at least 5:1. As referred to herein,“aspect ratio” of a fragment is the ratio of the diameter of thesmallest imaginary sphere that can enclose the object to the diameter ofthe largest imaginary sphere that can be completely inside the objectand tangent to the surfaces of the object. For example, the aspect ratioof a sphere is 1:1; in another example, the aspect ratio of a cylinderthat is 2 inches (50.8 mm) long and ¼ inch (6.35 mm) in diameter isslightly over 8:1; in yet another example, a film fragment of thepresent invention that is 1 mil (25.4 microns) in thickness, 1 inch(25.4 mm) in length, and 1 inch (25.4 mm) wide has an aspect ratio of1414:1.

In some embodiments, the compositions of the present invention comprisefragments having an aspect ratio of at least 10:1. In variousembodiments, the fragments have an aspect ratio of from 5:1 to 10,000:1,from 5:1 to 500:1, from 10:1 to 1,000:1, from 10:1 to 100:1, from 20:1to 100:1, or from 25:1 to 35:1.

In various embodiments, the film comprises a formulation colorant thatimparts a color to the film, the composition, or both. In variousembodiments, the film fragments contrast with the carrier, and arewhite, black, or of any color that is visible against or contrasts withthe carrier background. Formulation colorants among those useful hereininclude non-toxic water soluble dyes or pigment, such as, for example,metallic oxide “lakes.” In certain embodiments, the colorant is approvedfor incorporation into a food or drug by a regulatory agency, such asFD&C or D&C pigments and dyes approved by the FDA for use in the UnitedStates. Colorants among those useful herein include FD&C Red No. 3(sodium salt of tetraiodofluorescein), Food Red 17, disodium salt of6-hydroxy-5-{(2-methoxy-5-methyl-4-sulphophenyl)azo}-2-naphthalenesulfonicacid, Food Yellow 13, sodium salt of a mixture of the mono anddisulphonic acids of quinophtalone or 2-(2-quinolyl) indanedione, FD&CYellow No. (sodium salt of4-p-sulfophenylazo-1-p-sulfophenyl-5-hydroxypyrazole-3 carboxylic acid),FD&C Yellow No. 6 (sodium salt ofp-sulfophenylazo-B-naphtol-6-monosulfonate), FD&C Green No. 3 (disodiumsalt of4-{[4-(N-ethyl-p-sulfobenzylamino)-phenyl]-(4-hydroxy-2-sulfoniumphenyl)-methylene}-[1-(N-ethyl-N-p-sulfobenzyl)-Δ-3,5-cyclohexadienimine],FD&C Blue No. 1 (disodium salt ofdibenzyldiethyl-diaminotriphenylcarbinol trisulfonic acid anhydrite),FD&C Blue No. 2 (sodium salt of disulfonic acid of indigotin), andmixtures thereof in various proportions. In one embodiment, the colorantcomprises a water insoluble inorganic pigment, such as titanium dioxide,chromium oxide green, phthalocyanine green, ultramarine blue, ferricoxide, or a water insoluble dye lake. In some embodiments, dye lakesinclude calcium or aluminum salts of an FD&C dye such as FD&C Green #1lake, FD&C Blue #2 lake, D&C Red #30 lake or FD&C # Yellow 15 lake. Incertain embodiments, a water soluble dye, such as, for example, FD&CBlue #1, is contained within a water-insoluble polymer such as, forexample polyethylene such as that found in polyethylene beads (e.g.,Microblue Spectrabeads, sold by Micropowders, Inc.). In certainembodiments, the film comprises a dye such as D&C Red #30. In certainembodiments, a white colorant is used, for example titanium dioxide(TiO₂), titanium dioxide coated mica (e.g., Timiron), a mineral, or aclay. In certain embodiments, the colorant is a non-bleeding dye. Invarious embodiments, the film comprises a colorant at a level of from0.5% to 20% by weight of the film, or from 1% to 15% by weight of thefilm, or from 3% to 12% by weight of the film. In one embodiment, thecompositions of the present invention comprise a first plurality of filmfragments comprising a first color, and a second plurality of filmfragments comprising a second color. Preferably, the second color isdifferent than the first color.

The film of the present invention, in various embodiments, disintegratesduring use of the composition. In other embodiments, the film does notdisintegrate during use of the composition. In some embodiments, thefilm releases a material, such as a therapeutic active, into thecarrier. As referred to herein, “disintegrate” refers to physicaldisruption of the film or fragment material, so as to produce a film orfilm fragments of reduced size compared to the original film. Suchdisruption may be through mechanical, chemical, or physical-chemicalmeans. The disintegration can result, for example, from shearing,grinding, or exposure to elevated temperatures during use. In variousdentifrice embodiments of the present invention, such disintegrationresults from brushing of the composition on the teeth of the subjectusing the composition. In one embodiment, the film disintegrates so asto release a therapeutic active. In some embodiments, a film fragmentcan disintegrate into small pieces that are not visually discernable. Insome embodiments, the film fragments disintegrate to collectively form acolloid or gel.

In various embodiments, the film may comprise therapeutic actives. Asreferred to herein, a therapeutic active is a material that is usefulfor the prevention or treatment of a physiological disorder orcondition. Such disorders or conditions include those of the oral cavity(including the teeth and gingiva), skin, hair, and eyes. The specifictherapeutic active is preferably determined according to the desiredutility of the composition. Such actives include the following.

-   -   A. antimicrobial agents, such as triclosan, cetyl pyridium        chloride, domiphen bromide, quaternary ammonium salts,        sanguinarine, fluorides, alexidine, octonidine, EDTA, essential        oils such as thymol, methyl salicylate, eucalyptol and menthol,        and zinc compounds, and the like,    -   B. non-steroidal anti-inflammatory drugs, such as aspirin,        acetaminophen, ibuprofen, ketoprofen, diflunisal, fenoprofen        calcium, naproxen, tolmetin sodium, indomethacin, and the like,    -   C. anti-tussives, such as benzonatate, caramiphen edisylate,        menthol, dextromethorphan hydrobromide, chlophedianol        hydrochloride, and the like,    -   D. decongestants, such as pseudoephedrine hydrochloride,        phenylepherine, phenylpropanolamine, pseudoephedrine sulfate,        and the like,    -   E. anti-histamines, such as brompheniramine maleate,        chlorpheniramine maleate, carbinoxamine maleate, clemastine        fumarate, dexchlorpheniramine maleate, diphenhydramine        hydrochloride, diphenylpyraline hydrochloride, azatadine        meleate, diphenhydramine citrate, doxylamine succinate,        promethazine hydrochloride, pyrilamine maleate, tripelennamine        citrate, triprolidine hydrochloride, acrivastine, loratadine,        brompheniramine, dexbrompheniramine, and the like,    -   F. expectorants, such as guaifenesin, ipecac, potassium iodide,        terpin hydrate, and the like,    -   G. anti-diarrheals, such a loperamide, and the like,    -   H. H₂-antagonists, such as famotidine, ranitidine, and the like;        and    -   I. proton pump inhibitors, such as omeprazole, lansoprazole, and        the like,    -   J. general nonselective CNS depressants, such as aliphatic        alcohols, barbiturates and the like,    -   K. general nonselective CNS stimulants such as caffeine,        nicotine, strychnine, picrotoxin, pentylenetetrazol and the        like,    -   L. drugs that selectively modify CNS function such as        phenyhydantoin, phenobarbital, primidone, carbamazepine,        ethosuximide, methsuximide, phensuximide, trimethadione,        diazepam, benzodiazepines, phenacemide, pheneturide,        acetazolamide, sulthiame, bromide, and the like,    -   M. antiparkinsonism drugs such as levodopa, amantadine and the        like,    -   N. narcotic-analgesics such as morphine, heroin, hydromorphone,        metopon, oxymorphone, levorphanol, codeine, hydrocodone,        xycodone, nalorphine, naloxone, naltrexone and the like,    -   O. analgesic-antipyretics such as salycilates, phenylbutazone,        indomethacin, phenacetin and the like, and    -   P. psychopharmacological drugs such as chlorpromazine,        methotrimeprazine, haloperidol, clozapine, reserpine,        imipramine, tranylcypromine, phenelzine, lithium and the like.

The amount of medicament that can be used in the films can be dependentupon the dose needed to provide an effective amount of the medicament.

In various embodiments, therapeutic actives useful herein includeanticaries agents, tartar control agents, antiplaque agents, periodontalactives, breath freshening agents, malodour control agents, whiteningagents, antibacterials, steroids, anti-inflammatory agents, vitamins,proteins, conditioning agents, moisturizers, antiperspirant actives,deodorant actives, anesthetics, and mixtures thereof.

In certain oral care embodiments, the film or the oral care compositionmay comprise an oral care active, which is useful for the prevention ortreatment of an oral care disorder or condition. Oral care actives amongthose useful herein include abrasives, anticaries agents, tartar controlagents, antiplaque agents, periodontal actives, breath fresheningagents, malodour control agents, tooth desensitizers, salivarystimulants, whitening agents, and combinations thereof. Active materialsamong those useful herein are described in U.S. Pat. No. 6,596,298,Leung et al.

Tartar control agents among those useful herein include dialkali ortetraalkali metal pyrophosphate salts such as Na₄P₂O₇, K₄P₂O₇,Na₂K₂P₂O₇, Na₂H₂P₂O₇ and K₂H₂P₂O₇; long chain polyphosphates such assodium hexametaphosphate; and cyclic phosphates such as sodiumtrimetaphosphate. In some configurations, a polyphosphate is abeta.-phase calcium pyrophosphate, such as disclosed in U.S. Pat. No.6,241,974, White, Jr. In some embodiments, the film comprises ananticalculus agent at a level of 15 to 20% by weight of the film.

Odor reducing agents useful herein include sulfur precipitating agents.Such sulfur-precipitating agents include metal salts, such as a coppersalt or a zinc salt. Such salts include copper gluconate, zinc citrateand zinc gluconate. These zinc salts can be used in combination or inaddition to the zinc compounds included in the film. In variousembodiments, the film comprises sulfur precipitating agents at a levelof from 0.01 to 30% by weight of film, from 2% to 2.5% by weight offilm, or 10% to 20% by weight of film.

In a certain embodiments, the film and/or oral composition may include asaliva stimulating agent (a “succulent”). Such agents include thosedisclosed in U.S. Pat. No. 4,820,506, Kleinberg et al. In someconfigurations, a saliva stimulating agent can include a food acid suchas citric, lactic, malic, succinic, ascorbic, adipic, fumaric andtartaric acids. In various embodiments, the film comprises a salivastimulating agent at a level of from 0.01 to 12% by weight of the film,from 1% to 10% by weight of the film, or from 2.5% to 6% by weight ofthe film. In some embodiments, a saliva stimulating agent can be used inthe amelioration of dry mouth.

In certain oral care embodiments, the film comprises other activematerials, such as antibacterial agents such as magnolia extract,triclosan, grapeseed extract, thymol, methyl salicylate, eucalyptol,menthol, hop acids, cetyl pyridinium chloride, (including CPC/Zn andCPC+enzymes) and usnic acid; anti-inflammatory agents such a breathfreshening agents (for example zinc gluconate, zinc citrate, zincchlorite and alpha ionone); tooth desensitizers such as potassiumnitrate, desensitizing polymers, and desensitizing minerals;anti-inflammatory agents such as magnolia extract, ursolic acid; aloe,and cranberry extract; vitamins such as pantheon, retinyl palmitate,folic acid, tocopherol acetate and Vitamin A; herbs or herbal extractssuch as rosemary, oregano, chamomilla recutita, mentha piperita, salviaofficinalis, orcommiphora and myrrha; proteins, such as milk proteinsand enzymes such as peroxide-producing enzymes, amylase,plaque—disrupting agents such as papain, glucoamylase, glucose oxidase,and “next generation” enzymes; whitening agents such as hydrogenperoxide, urea peroxide and phosphate salts; medicinals, such as aspirin(acetyl salicylic acid), caffeine, and benzocaine; probiotics; abrasivessuch as silicas (including high cleaning silica); anti-caries agentssuch as stannous salts (e.g., stannous fluoride) or amino fluoride; anitric oxide synthase inhibitor such as guanidinoethyldisulfide;calcium; antiattachment ingredients, such as polyumylphosphonic acid;preservatives such as Solbrol® (Bayer Chemicals AG); silicones;chlorophyll compounds, anti-leukoplakia agents such as beta-carotene;anti-oxidants such as Vitamin E; and combinations thereof. In someembodiments, the films comprise such active materials at a concentrationof 0.01 to 30% by weight of film, from 2% to 25% by weight of the film,or from 10% to 20% by weight of film.

The oral compositions of certain embodiments include a zinc compound ina film that provides a source of zinc ions. The zinc compound can be asoluble or sparingly soluble compound of zinc with inorganic or organiccounter ions. Examples include the fluoride, chloride, chlorofluoride,acetate, hexafluorozirconate, sulfate, tartrate, gluconate, citrate,lactate, malate, glycinate, pyrophosphate, metaphosphate, oxalate,phosphate, carbonate salts, and oxides of zinc. Preferably, the zinccompound is zinc oxide, and is used as a replacement for conventionalanti-bacterial agents such as triclosan.

Zinc ions are derived from the zinc compound present in the film in thedentifrice composition in an effective amount. An effective amount ofzinc ions is defined as from at least 1000 ppm zinc ion, preferably2,000 ppm to 15,000 ppm. More preferably, zinc ions are present in anamount from 3,000 ppm to 13,000 ppm and even more preferably from 4,000ppm to 10,000 ppm. This is the total amount of zinc ions that is presentin the compositions for delivery to the tooth surface.

Examples of suitable zinc compounds that serve as zinc ion sources arezinc oxide, zinc sulfate, zinc chloride, zinc citrate, zinc lactate,zinc gluconate, zinc malate, zinc tartrate, zinc carbonate, zincphosphate, and other salts listed in U.S. Pat. No. 4,022,880.

In certain embodiments, the film and/or oral care composition includes apreservative. A preservative can be added in amounts from 0.001 wt % to5 wt %, preferably from 0.01 wt % to 1 wt % of the film. Non-limitingexamples of preservatives include sodium benzoate and potassium sorbate.

In certain embodiments, the entrainment of the therapeutic actives inthe film matrix suspended in the dentifrice or other compositionisolates these agents from interaction with reactive ingredients presentin the composition so that the agents are maintained substantiallyseparate from the reactive composition ingredients during manufactureand storage while subsequently being released from the film matrix whenthe composition is used. Isolation not only avoids adverse reactionsthat may occur between the therapeutic actives and other components thatare present in the carrier material, but also avoids dissolution of thetherapeutic actives and premature release of actives.

The compositions of the present invention comprise a carrier in which afilm, or fragments, is entrained. As referred to herein, a “carrier” isany material or composition in which a film can be entrained and issuitable for administration or application to the human or animalsubject to whom the composition is administered or applied. As referredto herein, “entrained” refers to the embedding or suspension of a filmin a carrier. In various embodiments comprising a plurality offragments, such fragments may be entrained by embedding, suspension,dispersion or other distribution of the fragments in the carrier. Invarious embodiments, the fragments are distributed substantiallyhomogenously throughout the carrier. In other embodiments, the fragmentsare not distributed homogenously in the carrier. In certain embodiments,the distribution of a plurality of film fragments is substantiallyisotropic within the carrier. Dentifrice compositions that include aplurality of film fragments dispersed or suspended in a carrier arecommercially available under the tradename Max Fresh® or Max White®,from Colgate-Palmolive Company, New York, N.Y.

The compositions of the embodiments may be described as comprising twophases, wherein one phase comprises a carrier and a second phasecomprises the aforementioned film or fragment. The term “phase” as usedherein denotes a physical phase as understood in the physical andmaterial sciences, i.e., a portion of a material whose properties andcomposition are uniform. However, a phase as used herein can bediscontinuous, i.e., a phase can comprise a plurality of separatecomponents. For example, a plurality of polymer film fragments ofidentical composition is considered to comprise a single phase. In someembodiments, a film fragment can be entirely embedded within thematerial comprising the first phase, or totally or partially exposed onthe surface of the first phase. For example, if the composition is adentifrice comprising both a gel and film fragments, a film fragment canbe totally surrounded by the gel, or partially or totally exposed on thesurface of the gel. In certain embodiments, compositions comprise morethan two phases. Such multi-phase compositions include those having twocarriers, each of which contributes a phase to the composition, inaddition to film fragments as described herein. Other multi-phasecompositions include those having a single carrier and two or morepluralities of fragments, wherein the pluralities of fragments havediffering compositions.

In various embodiments, the carrier is a liquid, semi-solid or solid. A“liquid” can be a liquid of low or high viscosity. A liquid can be aliquid such that flow is imperceptible under ambient conditions. Forexample, a soap, such as an ordinary bar of hand soap, can be considereda liquid herein. A liquid can be a thixotropic liquid. A “semi-solid” asused herein can be a gel, a colloid, or a gum. As used herein,semi-solids and liquids are fluids distinguished on the basis ofviscosity: a semi-solid is a high viscosity fluid, while a liquid haslower viscosity. There is no definitive dividing line between these twotypes of fluids. A semi-solid can, in certain embodiments, have aviscosity as high as thousands of mPa·s. Carriers among those usefulherein include liquids, pastes, ointments, and gels, and can betransparent, translucent or opaque.

In certain embodiments, the compositions of the present invention areoral care compositions, suitable for administration to the oral cavity.Such compositions include dentifrices, mouthwashes, dental gels,lozenges, beads, gums, oral strips, mints, liquid toothpastes, sprays,paint-on gels, lip balms, whitening strips, breath strips, oral chews,and combinations thereof. An oral care composition disclosed herein canbe used, for example, for cavity prevention, whitening, plaqueprevention or reduction, gingivitis prevention or reduction, tartarcontrol, sensitivity prevention or reduction, or breath malodorprevention or reduction, and stain prevention.

The specific composition of the carrier preferably depends on theintended use of the composition. In various embodiments, the carrier isaqueous, comprising from 5% to 95% water or from 10% to 70% water. Inother embodiments, the carrier is substantially non-aqueous. In adentifrice carrier, water content can be from 5% to 70%, from 10% to50%, or from 20% to 40%. When the presence of water will cause the filmto disintegrate, it is particularly preferred that the dried filmcontain no free water, in which the amount of water is substantially 0%,or negligible.

The carrier may comprise any of a variety of materials, includingemulsifiers, thickeners, fillers, and preservatives. In someembodiments, the carrier may include a functional or active material,such as those described above. In some embodiments, the carriercomprises the same functional material as the film.

In one embodiment, the carrier is suitable for use as a dentifrice. Insome embodiments, the carrier comprises a humectant, such as glycerine,sorbitol or an alkylene glycol such as polyethylene glycol or propyleneglycol. In some configurations, the carrier comprises a humectant at alevel of from 10% to 80% by weight, or 20% to 60% by weight of thecomposition. Carrier compositions among those useful herein aredisclosed in U.S. Pat. Nos. 5,695,746, Garlick, Jr., et al, and4,839,157, Mei-King Ng et al.

In various dentifrice embodiments, the carrier comprises thickeners,gelling agents or combinations thereof. Thickeners or gelling agentsuseful herein include inorganic, natural or synthetic thickeners orgelling agents. In some configurations, the carrier comprises thethickener and gelling agent at total levels of from 0.10% to 15% byweight, or from 0.4% to 10% by weight of the composition. Examples ofthickeners and gelling agents useful herein include inorganic thickeningsilicas such as: an amorphous silica, for example Zeodent® 165 (HuberCorporation); Irish moss; iota-carrageenan; gum tragacanth; orpolyvinylpyrrolidone. In certain embodiments, the carrier comprises apolishing agent, such as a silica, a calcined alumina, sodiumbicarbonate, calcium carbonate, dicalcium phosphate or calciumpyrophosphate. In various embodiments, the carrier can be a visuallyclear composition.

In various dentifrice embodiments, comprising a visually clear carrier,the composition comprises at least one polishing agent. Polishing agentsamong those useful herein include collodial silica, such as, forexample, Zeodent® 115 (Huber Corporation), and alkali metalaluminosilicate complexes (i.e., a silica comprising alumina). In someconfigurations, a polishing agent can have a refractive index close tothat of a gelling agent combined with water and/or humectant. In variousembodiments, the carrier comprises the polishing agent at a level offrom 5% to 70% by weight of the composition.

In certain dentifrices, the carrier comprises additional surfactants ormixture of surfactants. Surfactants among those useful herein includewater-soluble salts of at least one higher fatty acid monoglyceridemonosulfate, such as the sodium salt of the monsulfated monoglyceride ofhydrogenated coconut oil fatty acids; cocamidopropyl betaine; a higheralkyl sulfate such as sodium lauryl sulfate; an alkyl aryl sulfonatesuch as sodium dodecyl benzene sulfonate; a higher alkyl sulfoacetate;sodium lauryl sulfoacetate; a higher fatty acid ester of 1,2-dihydroxypropane sulfonate; and a substantially saturated higher aliphatic acylamides of a lower aliphatic amino carboxylic acid, such as those having12 to 16 carbons in the fatty acid, alkyl or acyl radicals; and mixturesthereof. Amides can be, for example, N-lauroyl sarcosine, and thesodium, potassium, and ethanolamine salts of N-lauroyl, N-myristoyl, orN-palmitoyl sarcosine. In various embodiments the carrier comprises thesurfactant at a level of from 0.3% to 5% by weight of composition, or0.5% to 3% by weight of composition.

The present invention also provides methods for making a dentifricecarrier. In one embodiment, water and at least one humectant aredispersed in a conventional mixer until a first homogeneous gel phase isformed. A polishing agent is added into the first homogeneous gel phase.The first homogeneous gel phase and the polishing agent are mixed untila second homogeneous gel phase is formed. A thickener, flavorant andsurfactants are added to the second homogeneous gel phase. Theseingredients are mixed at high speed under vacuum of 20 to 100 mmHg.

The compositions of the present invention are preferably stable undernormal conditions of storage. As referred to herein, “stable” refers tothe lack of significant adverse effect on one, and preferably all,compositional attributes such as appearance, flavor, rheology, andchemical composition of the composition. Preferably, stability in thepresent compositions includes the compositional and physical stabilityof film (including fragments, if any) in the composition. In variousembodiments a composition comprising a film is stable upon storage atambient temperature for at least two years. It is understood, however,that in some embodiments, an otherwise stable film can disintegrateduring use (as discussed above), for example, during toothbrushing usinga dentifrice composition.

In certain embodiments, a composition can comprise, in addition to filmfragments as described herein, two or more carriers, each of whichcontributes a phase to the composition. Such a composition can be stableto color bleeding. For example, a composition can include film fragmentsand a striped dentifrice such as that disclosed in U.S. Pat. No.6,315,986, Wong et al. In certain embodiments, the film fragments can beof different color(s) than the stripe(s) for enhanced aesthetic appeal.

The embodiments also provides processes for making compositionscomprising a film entrained in a carrier. In various embodiments, aplurality of fragments are combined with a carrier. In someconfigurations, a carrier and a plurality of film fragments can bemixed. In some configurations, the mixing can comprise slow stirring. Inone preferred embodiment, the process for making the compositioncomprising a carrier having distributed therein a plurality of lamellarfragments includes:

(a) providing the carrier;

(b) adding lamellar fragments of a film containing a relatively highconcentration of nonionic surfactants such as polysorbates to thecarrier to form a mixture; and

(c) homogenizing the mixture.

The term “homogenizing” as used herein refers to the admixture of thefragments and the carrier so as to attain a substantially homogeneousdistribution of fragments in the carrier. It should be noted, however,that the resulting composition still retains two-phase compositioncharacteristics. Homogenizing may be accomplished using any of a varietyof conventional homegenizers.

In another method, the film is added to a component of the carrier(e.g., to a humectant for a dentifrice). The remainder of the carrierthen may be made, and the mixture of film then added to the carrier.

In various embodiments, the present invention provides methods foradministering a functional material to a human or animal subject in needthereof, comprising topically applying to said subject a compositioncomprising a film entrained in a carrier, wherein the film includes arelatively high concentration of nonionic surfactants. As referred toherein, “administering” refers to any method by which a composition isapplied on or administered to the subject. In various embodiments, theadministration is topical, wherein the composition is applied to anexternal surface of the subject, such as to a surface of the oral cavity(e.g., teeth, gingival, and tongue. The specific route and method ofadministration will depend, of course, on the intended use of thecomposition. In one embodiment, the method additionally comprisesdisrupting the film after topically applying the film. Such disruptionmay be accomplished by any of a variety of methods, including chemicaland/or mechanical means. Chemical means include degradation of the filmby contact with water or a material present at the site ofadministration (e.g., saliva in an oral care application). Physicalmeans include agitation, grinding, and shear forces produced byapplication of physical energy to the composition during use (e.g.,brushing in a dentifrice application).

In various embodiments, the present invention provides methods for thetreatment of an oral care condition. As referred to herein, an “oralcare condition” is any disorder or condition which can be prevented ortreated by administration of a composition to the oral cavity, includingdisorders or conditions of the teeth, oral mucosa, gingiva and tongue.Such conditions include caries, gingivitis, periodontitis, and cosmeticconditions such as yellowing and malodour.

The embodiments described herein can be further understood by referenceto the following non-limiting examples.

Example 1

This example illustrates various formulations of polymeric filmscontaining therapeutic actives and varying amounts of nonionicsurfactants, in particular polysorbate 80.

TABLE 1 18% Menthol with 2% Polysorbate 80 Raw Materials Slurry Wt. %Dry Wt. % Water 80.0 — Methocel E5 (HPMC) 8.1 40.2 Methocel E50 (HPMC)2.4 12.1 Cornstarch 3.2 16.1 Menthol 3.5 17.6 Titanium Dioxide 0.8 4.0Propylene Glycol 1.6 8.0 Polysorbate 80 (Tween 80) 0.4 2.0 Total: 100100

TABLE 2 51% Calcium Peroxide with 1.6% Polysorbate 80 Raw MaterialsSlurry Wt. % Dry Wt. % Water 69.0 — Methocel E5 (HPMC) 8.3 26.8 MethocelE50 (HPMC) 2.9 9.3 Calcium Peroxide 15.8 51.0 Titanium Dioxide 1.0 3.2Propylene Glycol 2.5 8.1 Polysorbate 80 (Tween 80) 0.5 1.6 Total: 100100

TABLE 3 45% Calcium Peroxide with 14% Polysorbate 80 Raw MaterialsSlurry Wt. % Dry Wt. % Water 64.5 — Methocel E5 (HPMC) 8.3 23.4 MethocelE50 (HPMC) 2.9 8.2 Calcium Peroxide 15.8 44.5 Titanium Dioxide 1.0 2.8Propylene Glycol 2.5 7.0 Polysorbate 80 (Tween 80) 5.0 14.1 Total: 100100

TABLE 4 31% Calcium Peroxide plus 15% Zeodent 105 with 14% Polysorbate80 Raw Materials Slurry Wt. % Dry Wt. % Water 63.5 — Methocel E5 (HPMC)8.3 22.7 Methocel E50 (HPMC) 2.9 8.0 Calcium Peroxide 11.3 31.0 TitaniumDioxide 1.0 2.7 Zeodent 105 (silica) 5.5 15.1 Propylene Glycol 2.5 6.8Polysorbate 80 (Tween 80) 5.0 13.7 Total: 100 100

TABLE 5 5% Carbopol 974 with 10% Polysorbate 80 Raw Materials Slurry Wt.% Dry Wt. % Water 81.0 — Methocel E5 (HPMC) 8.0 42.2 Methocel E50 (HPMC)2.4 12.7 Calcium Peroxide 3.2 17.0 Titanium Dioxide 0.8 4.2 Carbopol 9741.0 5.0 Propylene Glycol 1.6 8.4 Polysorbate 80 (Tween 80) 2.0 10.5Total: 100 100

Table 1 is a formula for a currently available commercial film productcontaining 2% by weight polysorbate 80 (commercially available inMaxFresh® toothpaste formulations, available from Colgate-PalmoliveCompany, New York, N.Y.). The film contains a low level of polysorbate80 (2% wt) and does not contain a high loading of solids (17.6% wtmenthol).

Table 2 is a formula for a whitening film that contains calcium peroxideas the whitening agent. This formulation has a low level of polysorbate80 (1.6% wt) and a high level of calcium peroxide (51% wt). The filmproduced was not robust and cracked on drying.

Table 3 is a formula for a whitening film that contains calcium peroxideas the whitening agent. This formulation has an increased level ofpolysorbate 80 (14.1% wt) and a high level of calcium peroxide (45% wt).The film produced was robust and able to contain the high solids loadingof calcium peroxide.

Table 4 is a formula for another whitening film that contains twowhitening agents, calcium peroxide and Xeodent 105. The film contains anincreased level of polysorbate 80 (13.7% wt) and a high level of calciumperoxide and Xeodent 105 (46% wt combined). The film produced wasrobust.

Table 5 is a formula for a mucoadhesive film that contains amucoadhesive agent called Carbopol 974. The film contains an increasedlevel of polysorbate 80 (10.5% wt) and the formula is also robust.

The examples and other embodiments described herein are exemplary andnot intended to be limiting in describing the full scope of compositionsand methods of this invention. Equivalent changes, modifications andvariations of specific embodiments, materials, compositions and methodsmay be made within the scope of the present invention, withsubstantially similar results.

1. An oral care composition comprising a film entrained in a carrier,wherein the film comprises a nonionic surfactant in an amount from 2% byweight of the film to 20% by weight of the film.
 2. The oral carecomposition of claim 1, wherein the composition is in the form of adentifrice.
 3. The oral care composition of claim 1, wherein thenonionic surfactant comprises a polysorbate.
 4. The oral carecomposition of claim 3, wherein the polysorbate is selected from thegroup consisting of polysorbate 20, polysorbate 40, polysorbate 60,polysorbate 80, and combinations thereof.
 5. The oral care compositionof claim 4, wherein the polysorbate is polysorbate
 80. 6. The oral carecomposition of claim 1, wherein the film further comprises a therapeuticactive.
 7. The oral care composition of claim 1, wherein the therapeuticactive is present in the film in an amount of from 20% by weight of thefilm to 65% by weight of the film.
 8. The oral care composition of claim1, wherein the film is present in an amount of from 0.1% to 5.0% byweight of the total weight of the composition.
 9. The oral carecomposition of claim 8, wherein the film is present in an amount of from0.25% to 3.0% by weight of the total weight of the composition.
 10. Theoral care composition of claim 9, wherein the film is present in anamount of from 0.5% to 2.0% by weight of the total weight of thecomposition.
 11. A method of making an oral care composition comprisinga film entrained in a carrier wherein the film comprises a nonionicsurfactant in an amount from 5% by weight of the film to 20% by weightof the film, the method comprising: (a) providing the carrier; (b)adding lamellar fragments of the film comprising the nonionic surfactantin an amount from 5% by weight of the film to 20% by weight of the film;and (c) homogenizing the mixture.
 12. The method of claim 11, whereinthe nonionic surfactant is polysorbate
 80. 13. The method of claim 11,wherein the film further comprises a therapeutic active.
 14. The methodof claim 13, wherein the therapeutic active is present in the film in anamount of from 20% by weight of the film to 65% by weight of the film.15. The method of claim 11, wherein the film is present in an amount offrom 0.1% to 5.0% by weight of the total weight of the composition. 16.A method for administering an active to a human or animal subject inneed thereof comprising topically applying to the subject an oral carecomposition comprising a film, wherein the film comprises a nonionicsurfactant in an amount from 5% by weight of the film to 20% by weightof the film.
 17. The method of claim 16, further comprising disruptingthe film after the topical application.
 18. The method of claim 16,wherein the nonionic surfactant is polysorbate
 80. 19. The method ofclaim 16, wherein the film further comprises a therapeutic active. 20.The method of claim 19, wherein the therapeutic active is present in thefilm in an amount of from 20% by weight of the film to 65% by weight ofthe film.